Seroset 8 mg/4 ml (IM/IV Injection)
Medicine Details
| Category | Details |
|---|---|
| Generic | Ondansetron |
| Company | Globex pharmaceuticals ltd |
| Also available as |
Indications
- Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy
- Prevention and treatment of post-operative nausea and vomiting
- Prevention of radiotherapy-induced nausea and vomiting
Description
Seroset oral soluble film is an orally dissolving film designed to be applied on top of the tongue, dissolving within 20 seconds and swallowed with saliva. Active ingredient: Ondansetron base, the racemic form of Ondansetron, a selective blocking agent of the serotonin 5-HT3 receptor type.
Dosage
- Chemotherapy-Induced Nausea and Vomiting:
- 8 mg tablet/orodispersible tablet
- 4 mg orodispersible tablet
- Injection
- Radiotherapy-Induced Nausea and Vomiting:
- 8 mg tablet/orodispersible tablet
- 4 mg orodispersible tablet
- Injection
- Postoperative Nausea and Vomiting:
- 8 mg tablet/orodispersible tablet
- 4 mg orodispersible tablet
- Injection
- Pediatrics:
- Injection: 4 mg
- Injection: 0.1 mg/kg
- 5 ml (4 mg) Ondansetron Oral Solution
- 10 ml (8 mg) Ondansetron Oral Solution
- 20 ml (16 mg) Ondansetron Oral Solution
- Oral Solution:
- 10 ml (8 mg) Ondansetron Oral Solution 3 times daily
- 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy
- Oral Soluble Film:
- 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy
- One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later
Pharmacology
Ondansetron is a potent, highly selective 5HT3 receptor-antagonist, blocking the initiation of vomiting reflex. Its precise mode of action in the control of nausea and vomiting is not fully known.
Administration
- Tear the pouch along the edge tear mark
- Place the film on top of the tongue
- Swallow after the Onsaf oral soluble film dissolves
Interaction
Seroset does not induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Inducers or inhibitors of these enzymes may change the clearance and half-life of Seroset.
Contraindications
Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.
Side Effects
- Headache
- Constipation
- Diarrhea
- Rash
- Sensation of flushing or warmth
- Hiccups
- Liver enzyme abnormalities
- Anaphylaxis
- Brochospasm
- Tachycardia
- Angina
- Hypokalemia
- Shortness of breath
Pregnancy & Lactation
No evidence of impaired fertility or harm to the fetus due to Ondansetron. Caution should be exercised when Ondansetron is administered to a nursing woman.
Precautions & Warnings
- Hypersensitivity reactions reported
- Should not be used instead of nasogastric suction
- May mask a progressive ileus and/or gastric distension post-abdominal surgery or in chemotherapy-induced nausea and vomiting patients
Use in Special Populations
- Dosage Adjustment for Patients With Impaired Renal Function: Same as for general population
- Dosage Adjustment for Patients With Impaired Hepatic Function: Single maximal daily dose of 8 mg is recommended in severe hepatic impairment
- 4 years of age or younger: Little information is available about dosage
- Over the age of 65: No dosage adjustment needed
Therapeutic Class
Anti-emetic drugs
Storage Conditions
Store at temperature not exceeding 30°C in a dry place. Protect from light and moisture.